Category Archives: Pharmaceuticals

A tapered and pulsed regimen with vancomycin — with diligent follow-up — can achieve significant cure rates in recurrent Clostridium difficile (C. difficile) infected patients, according to a new study.

Researchers from Loyola Medicine retrospectively studied 100 vancomycin taper and pulse treatment patients treated for recurrent C. difficile infection between January 1, 2009 and December 31, 2014. Their clinic, the study authors wrote, has been a referral center for the infection for the past decade.

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However, despite the guidelines for treatment of recurrent C. difficile infection being not too different than recurrent episodes – except for the use of vancomycin when the case is severe – there have not been many studies on this vancomycin taper and pulsed dosing.

The researchers observed that after a referral, the confirmed recurrent C. difficile patients were treated with a vancomycin taper and pulse regimen: a taper of vancomycin to once-daily, followed by alternate day dosing; or once-daily followed by alternate day dosing; followed by every third day, for at least 2 weeks. After this regimen, all patients had 90-day follow-up documentation.

On average, the patients in the clinic were on their third C. difficile diarrhea episode. Half of the patients had also received a standard course of vancomycin, while another third had received some type of vancomycin taper regimen, the researchers said.

Despite the fact that many of these patients were a “treatment experienced” population, 75% of the patients who received a supervised vancomycin taper and pulsed regimen achieved a cure, study author Stuart Johnson MD, . He added that the results were further improved for patients who received the expended pulse phase: 81% achieved a cure.

“The findings were not unexpected to us, but I think that many clinicians will be surprised how well a deliberate, prolonged vancomycin taper and pulse regimen – with careful follow up – works,” Johnson said.

There were no significant differences among the patients in terms of gender, age, concomitant antibiotics, proton pump inhibitor use, histamine receptor-2 blocker use, or patients with a regimen greater than 10 weeks in length, the researchers continued.

The researchers added that their finding of improved cure rates with alternate-day dosing plus every third day dosing over strictly alternate-day dosing is consistent with the hypothesis that pulsed dosing can promote a cyclical decrease in spore burden, they wrote. This can also permit the resetting of normal microbiota in the gut.

Johnson concluded that the clinical implications of the study show most recurrent C. difficile patients do not need fecal microbiota transplant (FMT).

“FMT has received an enormous amount of press and this procedure is now widely available throughout the US,” Johnson said. “FMT is attractive because it addresses one of the primary mechanisms involved with recurrent C. difficile infection, a marked disruption of the resident bacteria that populate the intestine and provide an important host defense against C. difficile.

Although physicians screen donor feces for “known pathogens,” not all is known of the potential complications to come from FMT, Johnson said.

“In addition, it appears that efficacy with a carefully supervised vancomycin taper and pulse regimen compare to that achieved with FMT,” Johnson said.

About 2 million Americans catch drug-resistant infections each year, and 23,000 die, according to the CDC.

As superbugs capture attention as a worldwide health threat, Washington University will be part of a national campaign against drug-resistant bacteria with a $2 million federal grant. The Centers for Disease Control and Prevention awarded $14 million to 25 medical schools and other organizations for research into how microorganisms in the body, known as the microbiome, can track and prevent infections by outsider, drug-resistant germs.

“Understanding the role the microbiome plays in antibiotic-resistant infections is necessary to protect the public’s health,” Dr. Tom Frieden, CDC director, said in a statement. “We think it is key to innovative approaches to combat antibiotic resistance, protect patients, and improve antibiotic use.”

The microbiome includes “good” bacteria and other beneficial organisms that live in the skin and in the digestive and respiratory tracts. Antibiotics that are supposed to fight “bad” bacteria can disrupt the natural habitat by unbalancing the good and bad. Then drug-resistant bacteria can take over and create an environment for out-of-control bugs, including methicillin-resistant staphylococcus aureus (MRSA), carbapenem-resistant enterobacteriaceae (CRE) and clostridium difficile (C. diff.).

Overexposure to antibiotics has been blamed for the rise in superbugs, with the CDC estimating that one in three antibiotic prescriptions is unnecessary.

The research project will look at how early exposure to antibiotics affects the development of the microbiome and whether there are better ways to protect the microbiome.

Four teams of researchers at Washington University were named to the local project:

Dr. Jeffrey Henderson will lead a team working to identify how diet and metabolism interact with the gut microbiome in a study to combat C. diff. intestinal infections.

A team led by Gautam Dantas will study the long-term effects of antibiotic therapy in premature infants and how their digestive microbiomes are affected.

Dr. Jennie Kwon will study antibiotics and the microbiome as it relates to pneumonia.

Dr. Brian Gage will help look at hemorrhages linked to the use of blood thinners.

The United Nations General Assembly focused on superbugs — in a rare discussion of health issues. The meeting comes after a new superbug resistant to last-resort antibiotics infected a Pennsylvania woman over the summer, and a resistant strain of E. coli was recently found in a 2-year-old Connecticut girl.

The CDC recommends increased testing for the superbug gene among certain types of E. coli bacteria that show resistance to the powerful antibiotic colistin. The gene spreads readily among bacteria, and it could make these multi-drug-resistant strains almost impossible to treat.

A cluster of gonorrhea infections in Hawaii has shown resistance to all treatments. Doctors are increasingly worried that the common sexually transmitted disease is gaining strength as one of the most urgent superbug threats. If untreated, the disease can lead to infertility.

An accurate diagnosis via laboratory testing is critical for effectively treating persistent diarrhea lasting more than 2 weeks, as the often poorly recognized syndrome can be caused by different pathogens than acute diarrhea, according to a clinical review recently published in JAMA.

“I’d like to educate doctors about the importance of taking the history and assessing duration of illness,” Herbert L. DuPont, MD, Director of the Center for Infectious Diseases at The University of Texas Health Science Center at Houston School of Public Health, said in a press release. “For acute diarrhea, the lab has a minimal role, restricted to patients passing bloody stools. If a patient has had diarrhea for 2 weeks or more, the doctor should focus on the cause of the disease through laboratory testing, with an emphasis on parasites.”

DuPont performed a review of relevant literature published up to February 2016 to provide an overview of the epidemiology, etiology, diagnosis and management of persistent diarrhea in immunocompetent patients.

Common causes of persistent diarrhea

Although acute diarrhea is usually caused by viruses or toxins, persistent diarrhea is usually caused by bacteria or parasites, DuPont wrote.

Protozoa are the most common parasitic cause of persistent diarrhea, including Giardia, Cryptosporidium and Cyclospora, whereas Entamoeba histolytica, Cystoisospora belli, Dientamoeba fragilis, Strongyloides stercoralis and Microsporidia species are less common.

Clostridium difficile can cause recurrent diarrhea in patients receiving antibiotics in health care settings, and viral agents, such as norovirus, and helminths can also cause persistent diarrhea.

“Parasites are more common in the developing world. Consequently, persistent diarrhea is more common in these areas and in local populations or people traveling to these locations,” DuPont wrote. “Persistent diarrhea occurs in approximately 3% of international travelers to developing regions.” Parasitic infection is less common in industrialized regions, where foodborne and waterborne pathogens and C. difficileare more common causes, he added.

Duration of illness should be determined by health care providers when developing an evaluation plan, and the clinical assessment of patients with persistent diarrhea lasting more than 14 days should include a complete history, physical examination and diagnostic testing for infectious or noninfectious etiologies.

“The longer the duration of illness, the more likely it is that parasitic pathogens or noninfectious causes will eventually be identified,” DuPont wrote.

Previously, bacterial pathogens were identified using stool culture-based methods, and parasites are often identified using commercial enzyme immunoassay tests or microscopy. However, the recent advent of multiplex polymerase chain reaction (PCR) platforms enable simultaneous testing for a number of bacterial, viral and parasitic enteropathogens by identifying their DNA sequences.

“These new tests are easy to use, are capable of detecting a broad range of pathogens and represent a significant improvement over culture-based diagnostic approaches,” DuPont said in the press release. “The technology needs to be more widely available. Diagnosis is critical when treating persistent diarrhea.” However, false positive results are problematic, he wrote.

Treatment depends on diagnosis

After treating any dehydration with oral rehydration therapy, a laboratory test should be performed to determine the cause of persistent diarrhea to determine the appropriate treatment. However, a single 1,000 mg dose of empirical azithromycin is appropriate concurrent to the lab test for adults who have traveled to the developing world, as bacterial causes that lab tests cannot usually identify are common.

Although antimicrobial agents are recommended for a number of pathogens, the antibiotic choice should be optimized based on the pathogen’s susceptibility to prevent antimicrobial resistance.

At least 30 percent of antibiotics are unnecessarily prescribed, contributing to the rise of debilitating and sometimes deadly bacteria-resistant superbugs, according to a study released Tuesday – May 3, 2016.

To reach this conclusion, researchers tracked antibiotic use in doctors’ offices and emergency departments between 2010 and 2011 throughout the United States. The study results were published in Journal of the American Medical Association by the Centers for Disease Control and Prevention along with Pew Charitable Trusts.

The findings showed that doctors needlessly wrote prescriptions for viruses, such as the common cold, viral sore throats and other ailments that can’t be cured with antibiotics. More than 47 million excess prescriptions put patients in harm’s way for allergic reactions and superbugs, such as Clostridium difficile, or C. diff.

“The rampant misuse of antibiotics is probably the leading infectious disease public health threat the world faces,” Dr. Amesh Adalja, a UPMC infectious disease specialist, said after learning of the study results. “The spread of antimicrobial-resistant bacteria and the infections they cause are a crisis and, if allowed to continue, will drag civilization back decades.”

Superbugs kill 23,000 Americans a year and sicken 2 million, according to the CDC.

Last year, the White House set its sights on superbugs, releasing a plan to combat the proliferation of antibiotic-resistant bacteria. The plan’s goal is to reduce outpatient antibiotic use by 50 percent and inpatient use by 20 percent by 2020.

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Appili Therapeutics announced that the Food and Drug Administration (FDA) has granted Orphan Drug designation for ATI-1501 (metronidazole) for the potential treatment of Clostridium difficile infection (CDI) in children.

ATI-1501 is a taste-masked reformulation of metronidazole. For most children, metronidazole tablet is highly unpalatable due to its bitter taste. This reformulation has the potential to improve compliance rates in children in need for a safe and effective treatment for CDI.

Researchers are scheduled to provide more than 30 scientific data presentations on the company’s established and investigational infectious disease medicines and vaccines at this year’s 26th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID)

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Merck, known as MSD outside the United States and Canada, announced that researchers are scheduled to provide more than 30 scientific data presentations on the company’s established and investigational infectious disease medicines and vaccines at this year’s 26th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID)
April 9-12 , 2016 in Amsterdam, Netherlands.

Presentations at ECCMID will include new data analyses from two pivotal Phase 3 clinical trials of bezlotoxumab, Merck’s investigational compound for the prevention of Clostridium difficile (C. difficile) infection recurrence in patients on standard-of-care antibiotics for the treatment of C. difficile infection. Researchers also will present studies showing updated data on the in vitro activity of ZERBAXA® (ceftolozane and tazobactam) 1.5 g. ZERBAXA is indicated for the treatment of adults with complicated urinary tract infections (cUTI), including pyelonephritis, and in combination with metronidazole, complicated intra-abdominal infections (cIAI) caused by designated susceptible Gram-negative and Gram-positive bacteria. For more information, including a complete list of abstract titles, please visit the ECCMID website at www.eccmid.org.

Merck’s commitment to infectious diseases

For more than 80 years, Merck has contributed to the discovery and development of novel medicines and vaccines to combat infectious diseases. In addition to a combined portfolio of antibiotic and antifungal medicines, vaccines, and medicines for HIV and HCV, Merck has multiple programs that span discovery through late-stage development. Merck currently has 10 compounds in Phase 2/Phase 3 clinical trials for the potential treatment or prevention of infectious diseases.

About ZERBAXA

ZERBAXA (ceftolozane and tazobactam) is an antibacterial combination product for intravenous infusion consisting of the cephalosporin antibacterial drug ceftolozane sulfate and the beta-lactamase inhibitor tazobactam sodium.

ZERBAXA is approved in the United States and is indicated in adult patients for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis, caused by the following Gram-negative microorganisms: Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, and Pseudomonas aeruginosa. ZERBAXA used in combination with metronidazole is indicated in adult patients for the treatment of complicated intra-abdominal infections (cIAI) caused by the following Gram-negative and Gram-positive microorganisms: Enterobacter cloacae, Escherichia coli, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa, Bacteroides fragilis, Streptococcus anginosus, Streptococcus constellatus, and Streptococcus salivarius.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of ZERBAXA and other antibacterial drugs, ZERBAXA should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

Important Safety Information about ZERBAXA

Patients with renal impairment: Decreased efficacy of ZERBAXA has been observed in patients with baseline CrCl of 30 to ≤50 mL/min. In a clinical trial, patients with cIAIs with CrCl ≥50 mL/min had a clinical cure rate of 85.2% when treated with ZERBAXA plus metronidazole vs 87.9% when treated with meropenem. In the same trial, patients with CrCl 30 to ≤50 mL/min had a clinical cure rate of 47.8% when treated with ZERBAXA plus metronidazole vs 69.2% when treated with meropenem. A similar trend was also seen in the cUTI trial. Monitor CrCl at least daily in patients with changing renal function and adjust the dose of ZERBAXA (ceftolozane and tazobactam) accordingly.

Hypersensitivity: ZERBAXA is contraindicated in patients with known serious hypersensitivity to ceftolozane/tazobactam, piperacillin/tazobactam, or other members of the beta-lactam class. Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients receiving beta-lactam antibacterials. Before initiating therapy with ZERBAXA, make careful inquiry about previous hypersensitivity reactions to cephalosporins, penicillins, or other beta-lactams. If an anaphylactic reaction to ZERBAXA occurs, discontinue use and institute appropriate therapy.

Clostridium difficile–associated diarrhea (CDAD), ranging from mild diarrhea to fatal colitis, has been reported with nearly all systemic antibacterial agents, including ZERBAXA. Careful medical history is necessary because CDAD has been reported to occur more than two months after the administration of antibacterial agents. If CDAD is confirmed, antibacterial use not directed against C. difficile should be discontinued, if possible.

Development of drug-resistant bacteria: Prescribing ZERBAXA in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.

Adverse reactions: The most common adverse reactions occurring in ≥5% of patients were headache (5.8%) in the cUTI trial, and nausea (7.9%), diarrhea (6.2%) and pyrexia (5.6%) in the cIAI trial.

About Merck

For 125 years, Merck has been a global health care leader working to help the world be well. Merck is known as MSD outside the United States and Canada. Through our prescription medicines, vaccines, biologic therapies, and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to health care through far-reaching policies, programs and partnerships. For more information, visit www.merck.com and connect with us on Twitter, Facebook, YouTube and LinkedIn.

Forward-Looking Statement of Merck & Co., Inc., Kenilworth, N.J., USA

This news release of Merck & Co., Inc., Kenilworth, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline products that the products will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s 2015 Annual Report on Form 10-K and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).

You can customize maps and tables to show antibiotic resistance patterns in Healthcare-Associated Infections (HAI’s) by filtering the data by geographical area (national, regional, and state), time period, event type, and patient age.

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